EN   EN  
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2019) XXX  draft  
 
COMMISSION REGULATION (EU) No …/..  
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council on the Registration, Evaluation, Authorisation and Restriction of 
Chemicals ("REACH") as regards lead and its compounds  
(Text with EEA relevance)  EN 1  EN COMMISSION REGULATION (EU) …/..  
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council on the Registration, Evaluation, Authorisation and Restriction of 
Chemicals (REACH)  as regards lead and its compounds  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulat ion (EC) No 1907/2006 of the European Parliament and of the 
Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending 
Directive 1999/45/EC and  repealing Council Regulation (EEC) No 793/93 and Commission 
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission 
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC1, and in particular Article 
68(1) thereof,  
Whereas:  
(1) On 16 December 2016 , the European Chemicals Agency (‘the Agency’)  
submitted, at the request of the Commiss ion, a dossier2 pursuant to Article 69 (1) 
of Regulation (EC) No 1907/2006  (‘the Annex XV dossier ’), demonstrat ing that 
releases of lead  from articles produced f rom polymers or copolymers of vinyl 
chloride (PVC) containing  lead stabilisers, during their life -cycle, contribute 
directly and indirectly to human exposure to lead.  The dossier proposed  to ban 
the use of lead and lead compounds in articles  produced from PVC . Moreover, it 
proposed that  PVC articles containing a concentration of lead equal or greater 
than 0.1% of the PVC material  should not be placed on the market . A number of 
derogations  to this restriction, inter alia for rec overed  PVC material , were also 
contained in the proposal.     
(2) Lead is a toxic substance which affects the development of the nervous system, 
produces chronic kidney disease and has adverse effects on blood pressure. 
Although no  threshold for neurodevelopmental effects in chi ldren and for renal 
effects has been established , according to the European Food Safety Agency  the 
current human exposure to lead from food and other sources still exceeds the 
tolerable exposure levels and leads to adverse neurodevelopmental effects in 
children3.  
                                                 
1 OJ L 396, 30.12.2006, p . 1. 
2  https://echa.europa.eu/documents/10162/e70a ee23 -157b -b2a4 -2cae-c42a1278072c  (report);  
https://echa.europa.eu/documents/10162/cc1c37a8 -22f9-7a7a -cb33 -5c29edba7094  (annex)  
3 EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on Lead in Food. 
EFSA Journal 2010; 8(4):1570.      EN 2  EN (3) Lead stabilisers in PVC articles allow the PVC to endure longer fabrication 
(heating) time and protect it against photo -degradation. Industry in the Union 
voluntarily phased  out the use of lead stabilisers in PVC and reported  that th at 
process was successfully completed in 20154. PVC articles containing lead, 
especially construction products, have long service lives, remaining in use for 
periods exceeding several decades, after which they become waste upon disposal 
and may undergo  recyc ling, potentially re -introducing lead into  products  via the 
recovered PVC material. Given the phase -out of lead stabilisers in the U nion, the 
Agency calculated  that 90  % of the estimated total emissions of lead from PVC 
articles in the Union  in the year 20 16 was attributable to imported PVC articles . 
(4) Considering that lead compounds cannot stabilise PVC in an effective way at 
concentra tions below approximately 0 ,5 % by weight , the concentration limit of 
0,1 % proposed by the Agency  should ensure that the intentional addition of lead 
compounds as stabilisers during PVC compounding can no longer occur in the 
Union. 
(5) Except for certain lead -containing pigments, which are subject to authorisation 
under REACH  and specifically exempted under the proposed restriction, no 
other lead compounds than  stabilisers  are used in PVC. To facilitat e the 
enforcement of the proposed restriction, it is therefore appropriate to extend the 
scope of the restriction to all lead and lead compounds, thereby mak ing it 
unnecessary to determine the specific identity and function of the lead 
compounds present in the PVC material.   On 5 December  2017, the Agency’s 
Committee for Risk Assessment (‘RAC’) adopted its opinion5, concluding that 
the restriction proposed by  the Agency  is the most appropriate Union -wide 
measure to address  the identified risks posed by lead compounds present as 
stabilisers in PVC articles  in terms of effectiveness in reducing  such risks , 
practicality and monitorability . The RAC proposed modifi ed derogation s from  
the restriction in relation to  certain articles containing recovered PVC .  
(6) On 15 March 2018 , the Agency’s Committee for Socio -Economic Analysis 
(‘SEAC’) adopted its opinion in which it concluded that the restriction  proposed  
by the Agency , as modified by both the RAC and the SEAC, was the most 
appropriate Union -wide measure to address the identified risk, in terms of its 
socioeconomic benefits and socioeconomic costs. The SEAC reached th at 
conclusion based on best available evidence,  taking into account the properties 
of lead as a non -threshold toxic substance and its impact on human health  and 
the affordability of the costs associated with the proposed restriction . 
Consideration was also given to the fact that there are suitable alte rnatives  
widely available and already used by supply chains  in the Union , the cost -
effectiveness of the restriction as well as  the result of  the break -even analysis .  
(7) The RAC agreed  to include a derogation for recovered PVC  articles and 
proposed  that highe r lead content limit s for rigid and flexible PVC recyclate  
should be established, respectively , at 2 % and 1  % by weight.  That proposal 
takes account of the estimation that the alternative to recycling such articles, i.e. 
                                                 
4 VinylPlus progress report of 201 7, p. 14; see  
https://vinylplus.eu/uploads/downloads/VinylPlus_Progress_Report_2017.pdf . 
5  https://echa.europa.eu/ documents/10162/86b00b9e -2852 -d8d4 -5fd7-be1e747ad7fa  (compiled RAC and 
SEAC opinion).  EN 3  EN disposal of PVC waste via landfilling and incineration , would increase emissions 
to the environment and not reduce risk . The different limits proposed take into 
account the current estimated average lead content of rigid and flexible PVC, the 
expected impact o n recycling  volumes  and the fact that the release of lead from 
flexible PVC is known to be higher compared to rigid PVC .  
(8) The SEAC agreed  with the Agency  that considering the projected evolution of 
the concentration of lead in recovered PVC, th at concentration will decrease 
sufficiently by 2035 – 2040 to allow articles made from recovered PVC to 
comply with the proposed general lead concentration limit of 0,1  %. Therefore , 
the derogation for article s made from recovered PVC should apply for 15 years. 
The SEAC further agreed that, in order to  account for the uncertainty with 
respect to  the future trends regarding  the amount of post-consumer PVC  waste 
going to recycling and its lead content , that period of application should be 
reassessed within 10 years .  
(9) It is expected that e ncap sulation techniques will allow  limit ing releases of lead 
from recovered flexible PVC  present in certain types of articles such as traffic 
management articles and waterproofing membranes, by enclosing the lead  
entirely with in a layer of newly produced  PVC o r other suitable material. Such 
techniques are not yet readily available and their implementation will require 
additional time and  capital investment from economic operators . It is therefore 
appropriate to lay down a transitional period . During this period of 6 years  
certain articles containing recovered flexible PVC do not need to be coated, if 
they are to be covered by  the derogation from the 0,1% general maximum lead 
content restriction for PVC in those articles.  After the transitional period, that 
derogation should only apply to the recovered flexible PVC contain ed in those 
articles if it is completely enclosed  by an outer layer  of newly produced PVC or 
other suitable material .   
(10) The proposed derogation for recovered PVC aims to achieve  an appropriate 
balance between the overall long -term benefits from circular use of th ose 
materials and the overall long -term health concerns relating  to that material .  
(11) A derogation is appropriate for PVC -silica separators in lead batteries in view of 
the low risks and the lack of suitable alternatives . According to information 
submitted by producers of those PVC separators suitable alternatives will be 
available in approximately 10 years .  
(12) The Agency’s  Forum for Exchange of Information on Enforcement was 
consulted on the proposed restriction and its opinion was taken into account , 
resulting in  a modified description of the scope and of the  derogations from  the 
proposed restriction .  
(13) The RAC and the Agenc y agreed that the uses of lead compounds other than as 
stabiliser s should be covered by the proposed  restriction  and to provide for a  
specific derogation for the lead pigments "lead sulfochromate  yellow " and "lead 
chromate molybdate sulfate red " from the restriction . Th ose pigments are  
currently subject to an existing application for authoris ation under  Regulation 
(EC) No 1907/2006  and are the only lead compounds known to be used in PVC 
for a purpose other  than stabilisation . In June 2018 the Age ncy published its 
intention to submit a restriction dossier relati ng to the risks stemming  from the 
use of the two lead pigments  pursuant to Article 69(2)  of Regulation (EC) No EN 4  EN 1907/2006 . The Commission will re -examine t he applicability of the derogation  
for th ose lead pigments following the outcome of that restriction process .  
(14) For reasons of consistency, a derogation should be laid down for articles already 
covered by Union legislation regulating lead content in PVC.  
(15) Considering that for enforcement purp oses it is essential to be able to distinguish 
articles that contain rec overed  PVC from those that do not, a requirement to 
mark all  articles covered by the derogation for articles containing recovered 
PVC  should be introduced.    
(16) Considering the  difficult ies to determine if PVC material in articles, especially 
imported articles , is of rec overed  origin , suppliers of articles benefitting from 
derogations associated to their content in recovered PVC should be able to prove 
the recovered origin of the material  by presenting documentary evidence. In the  
Union,  several schemes  are available to recyclers to support claims on the 
traceability of recovered PVC6. Given the lack of suitable practical means for 
enforcement authorities to verify recovery claims associated to recovered PVC 
in imported articles, such claims  should be substantiated via independent third 
party certification.    
(17) Economic operators should  be granted a period of 24 months in order to be able 
to adapt to the new requirements, dispose of their stock and communicate 
relevant information on the restriction within the ir supply chains. Furthermore, 
the restriction should not apply to articles already placed  on the market before 
the end of that period as that would give rise to considerable enforcement 
difficulties.  
(18) Regulation (EC) No 1907/2006 should th erefore be amended accordingly.  
(19) The measures provided for in this Regulation are in accordance w ith the opinion 
of the Committee established under Article 133 of Regulation (EC) No 
1907/2006 , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance wit h the Annex to 
this Regulation.  
Article  2 
This Reg ulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
                                                 
6  Examples of such schemes are the Recovinyl audit framework and the EuCertPlast certification for plastic recyclers.  In addition,  several 
other certification schemes are available in some Member States , all of which  are based on requirements  in EN 15343:2007 “Plastics 
recycling traceability and assessment of conformity and recycled content”.  EN 5  EN Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude Juncker